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Clinical Trials/NCT05205954
NCT05205954
Recruiting
Not Applicable

HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

Massachusetts General Hospital1 site in 1 country30 target enrollmentJuly 21, 2025
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ConditionsCirrhosisEnd Stage Liver DIseaseLiver CirrhosisLiver Disease Chronic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cirrhosis
Sponsor
Massachusetts General Hospital
Enrollment
30
Locations
1
Primary Endpoint
Escalation Rate
Status
Recruiting
Last Updated
9 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.

Registry
clinicaltrials.gov
Start Date
July 21, 2025
End Date
December 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nneka nnaoke Ufere

Assistant Professor of Medicine

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • •Adult patients ≥ 18 years old with diagnosis of cirrhosis based on histology, radiology, and/or elastography presenting to the emergency department or inpatient general medicine service
  • •Patients must have one of the following:
  • •Ascites (requiring diuretics or serial large volume paracenteses)
  • •Hepatic hydrothorax (requiring diuretics)
  • •Hepatic encephalopathy (requiring medications)

Exclusion Criteria

  • •All existing MGB home hospital criteria apply, with the following taking precedent for this specific condition
  • •History of solid organ transplantation
  • •On hemodialysis
  • •MELD score \> 20
  • •Score \<10 on Simplified Animal Naming Test (S-ANT1)
  • •Current admission for hemodynamically significant GI bleeding or alcohol withdrawal
  • •Require routine administration of controlled substances
  • •Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation

Outcomes

Primary Outcomes

Escalation Rate

Time Frame: 18 months

The intervention will be deemed feasible if less than 20% of enrolled patients have escalation of care back to the inpatient (brick-and-mortar) hospital

Secondary Outcomes

  • Patient Experience(Up to 90 days)
  • Adverse Event Reporting(Up to 90 days)
  • Acceptability(18 months)

Study Sites (1)

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